Biotech companyLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Boston ScientificLabelled by claude-sonnet-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list C2 Therapeutics with 10 510(k) clearances and 1 device recall. The most recent is a 510(k) clearance dated Jan 23, 2018: C2 CryoBalloon Ablation System.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Jan 23, 2018 | C2 CryoBalloon Ablation SystemK163684 · GEH | 510(k) clearances |
| Jan 6, 2017 | C2 CryoBalloon Ablation System - Controller Cap. C2 CryoBalloon Controller; Cryosurgical Unit, Cryogenic Surgical Device The affected prodClass II · The Controller Cap of the C2 CyroBalloon Ablation System may crack as it is tightened onto the controller. That could c | Device recalls |
| Jan 5, 2017 | C2 Cryoballoon Ablation SystemK161202 · GEH | 510(k) clearances |
| May 19, 2016 | C2 CryoBalloon Focal Pear CatheterK160994 · GEH | 510(k) clearances |
| Apr 13, 2016 | Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation SystemK152329 · GEH | 510(k) clearances |
| Jan 7, 2016 | Coldplay CryoBalloon® Ablation SystemK153541 · GEH | 510(k) clearances |
| Oct 13, 2015 | Boa Endoscopic ValveK152140 · OCX | 510(k) clearances |
| Jul 7, 2015 | Coldplay Full CryoBalloon Ablation System and Coldplay Swipe CryoBalloon Ablation SystemK151054 · GEH | 510(k) clearances |
| Apr 14, 2015 | Sidecar External Working ChannelK150083 · FED | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
