# K131523: Cryoballoon Focal Ablation System

- Pathway: 510(k) (Special)
- Applicant: C2 Therapeutics
- Decided: Aug 22, 2013 after 86 days
- Product code: GEH (Unit, Cryosurgical, Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4350
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K840536 (1984). 12 ancestors in all.
10 later devices descend from it; 3 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101825: Cryoballoon Ablation System, C2 Therapeutics (2010) Summary page 1.

## Most influential descendants
- K151054: Coldplay Full CryoBalloon Ablation System and Coldplay Swipe CryoBalloon Ablation System (2015), 8 descendants of its own
- K152329: Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation System (2016), 6 descendants of its own
- K161202: C2 Cryoballoon Ablation System (2017), 5 descendants of its own
- K163684: C2 CryoBalloon Ablation System (2018), 4 descendants of its own
- K190194: C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge (2019), 3 descendants of its own

## Recalls of this device
- Mar 30, 2018 · Class II · Z-2256-2018: The catheter alignment arrow printed onto the strain relief is not aligned with the detachment feature of the catheter connector, resulting in the potential for the catheter to be attached to the cont
- Jan 6, 2017 · Class II · Z-1477-2017: 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.

## Indications for use
The C2 Therapeutics CryoBalloon Focal Ablation System is intended to be used as a cryosurgical tool for the destruction of unwanted tissue in the field of general surgery. specifically for endloscopic applications.

Source page: https://510kreport.com/device/K131523
Methodology: https://510kreport.com/methodology