# C2 Therapeutics, Inc.

- Location (FDA's records): Redwood, Ca, CA
- FDA decisions: 10 (2010–2018): 10 510(k) clearances
- Names in FDA's records: C2 Therapeutics, Inc. (7); C2 Therapeutics (3)
- Product codes: GEH (8), OCX (1), FED (1)
- 510(k) review time since 2016: median 239 days, against 60 for FDA's reviews in the same codes and years (2 of 5 faster)
- Predicates its devices cite: 17 (9 its own); citations of its devices by later devices: 11 (9 its own)
- Recalls linked to its devices: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- CSA Medical, Inc.: 2 (https://510kreport.com/company/csa-medical)
- Barrx Medical, Incorporated: 2 (https://510kreport.com/company/barrx-medical)
- Endochoice, Inc.: 1 (https://510kreport.com/company/endochoice)
- Crospon, Ltd.: 1 (https://510kreport.com/company/crospon)
- Crymed Technologies, Inc.: 1 (https://510kreport.com/company/crymed-technologies)
- Chek-Med Systems: 1 (https://510kreport.com/company/chek-med-systems)

## Firms that cite its devices most
- Pentax Medical, A Division of Pentax of America, Inc.: 2 (https://510kreport.com/company/pentax-medical-a-division-of-pentax-of-america)

## Its most-cited devices
- K131523: Cryoballoon Focal Ablation System (2013), cited by 3
- K151054: Coldplay Full CryoBalloon Ablation System and Coldplay Swipe CryoBalloon Ablation System (2015), cited by 2
- K152329: Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation System (2016), cited by 2
- K161202: C2 Cryoballoon Ablation System (2017), cited by 1
- K152140: Boa Endoscopic Valve (2015), cited by 1
- K101825: Cryoballoon Ablation System (2010), cited by 1

## Recent decisions
- K163684: C2 CryoBalloon Ablation System (Jan 23, 2018)
- K161202: C2 Cryoballoon Ablation System (Jan 5, 2017)
- K160994: C2 CryoBalloon Focal Pear Catheter (May 19, 2016)
- K152329: Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation System (Apr 13, 2016)
- K153541: Coldplay CryoBalloon® Ablation System (Jan 7, 2016)
- K152140: Boa Endoscopic Valve (Oct 13, 2015)
- K151054: Coldplay Full CryoBalloon Ablation System and Coldplay Swipe CryoBalloon Ablation System (Jul 7, 2015)
- K150083: Sidecar External Working Channel (Apr 14, 2015)

Source page: https://510kreport.com/company/c2-therapeutics