FDA Clears C2 Therapeutics Cryoballoon System
C2 Therapeutics announced Wednesday it has received 510(k) clearance from the FDA for its Coldplay Cryoballoon full ablation and swipe ablation systems to treat precursors of esophageal cancer.
The company says the systems will provide endoscopists with more options to eliminate cancer precursor Barrett’s Esophagus and improve patient outcomes. BE develops as a result of chronic injury from gastroesophageal reflux disease. Over time, the esophageal lining is replaced with abnormal cells, putting patients at greater risk of developing cancer.
The systems have a highly compliant balloon catheters that are simultaneously inflated and cooled by inert refrigerant delivered through a disposable handheld unit. Company President and CEO Peter Garcia-Meza says the FDA approval will allow physicians to ablate larger areas of tissue in endoscopic applications.
The Redwood City, Calif., company was founded in 2007 to establish treatment options for BE. — John Bechtel