Recall Z-1477-2017— C2 Therapeutics, Inc.
Class II · Terminated
Class II FDA medical device recall by C2 Therapeutics, Inc., initiated 2017-01-06, terminated 2017-09-13. It names 3 FDA 510(k) clearances: K161202, K152329, K131523. Product: C2 CryoBalloon Ablation System - Controller Cap. C2 CryoBalloon Controller; Cryosurgical Unit, Cryogenic Surgical Device The affected product is the Controller Cap component only, which is provided to the customer already assembled onto the Controller. Model number: FG-1012 Product Usage: The C2 CryoBalloon Ablation System is intended for use as a cryosurgical tool in the field of general surgery, specifically for endoscopic applications, to include ablation of Barrett s Esophagus with dysplasia. It is a cryosurgical system with a nitrous oxide cooled balloon that is compatible with a commercially available endoscope with a minimum working channel inner diameter (ID) of 3.7 mm and length of 100 cm. The C2 CryoBalloon System is a system comprised of a Catheter (sterile), Controller (non-sterile), and Cartridge (non-sterile). The Device is used to ablate unwanted tissue by application of extreme cold. The balloon at the distal end of the Catheter comes in contact with tissue and is inflated with nitrous oxide. Tissue is visualized through the inflated balloon, and the treatment site is selected by adjusting the endoscope and Controller position. The nitrous oxide spray cools the balloon to ablate the unwanted tissue, and the nitrous oxide exhausts through the Controller.. Reason: The Controller Cap of the C2 CyroBalloon Ablation System may crack as it is tightened onto the controller. That could compromise the integrity and result in damage to the Controller Cap..
- Recalling firm
- C2 Therapeutics, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-01-06
- Terminated
- 2017-09-13
- Firm location
- Redwood City, CA, United States
510(k) clearances named in this recall
3 on FDA's record- K161202 — C2 Cryoballoon Ablation System
- K152329 — Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation System
- K131523 — CRYOBALLOON FOCAL ABLATION SYSTEM
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
C2 CryoBalloon Ablation System - Controller Cap. C2 CryoBalloon Controller; Cryosurgical Unit, Cryogenic Surgical Device The affected product is the Controller Cap component only, which is provided to the customer already assembled onto the Controller. Model number: FG-1012 Product Usage: The C2 CryoBalloon Ablation System is intended for use as a cryosurgical tool in the field of general surgery, specifically for endoscopic applications, to include ablation of Barrett s Esophagus with dysplasia. It is a cryosurgical system with a nitrous oxide cooled balloon that is compatible with a commercially available endoscope with a minimum working channel inner diameter (ID) of 3.7 mm and length of 100 cm. The C2 CryoBalloon System is a system comprised of a Catheter (sterile), Controller (non-sterile), and Cartridge (non-sterile). The Device is used to ablate unwanted tissue by application of extreme cold. The balloon at the distal end of the Catheter comes in contact with tissue and is inflated with nitrous oxide. Tissue is visualized through the inflated balloon, and the treatment site is selected by adjusting the endoscope and Controller position. The nitrous oxide spray cools the balloon to ablate the unwanted tissue, and the nitrous oxide exhausts through the Controller.
Reason for recall
The Controller Cap of the C2 CyroBalloon Ablation System may crack as it is tightened onto the controller. That could compromise the integrity and result in damage to the Controller Cap.
Data sourced from openFDA. This site is unofficial and independent of the FDA.