Coldplay CryoBalloon® Ablation System— 510(k) K153541

Substantially Equivalent

C2 Therapeutics, Inc.

FDA 510(k) clearance K153541 for Coldplay CryoBalloon® Ablation System, Substantially Equivalent on 2016-01-07. Applicant: C2 Therapeutics, Inc..

Clearance details

Applicant: C2 Therapeutics, Inc.
Product code: Code GEH
Advisory panel: General, Plastic Surgery
Date received: 2015-12-10
Decision date: 2016-01-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Redwood, Ca, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GEH

product code GEH

Death: 25
Injury: 351
Malfunction: 901
Total: 1,277

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.