MAUDE Adverse Event Report: CSA MEDICAL, INC TRUFREEZE CRYOSPRAY; UNIT CRYOSURGICAL ACCESSORIES

Model Number	CC3-01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	12/05/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2018, during a sct procedure, a (b)(6) year old female suffering from stage 4 lung cancer, experienced a bilateral pneumothorax.The procedure was performed in the or.An 8.5 et tube was being used and the cuff was down the patient was off the ventilator as per protocol.The treatment site was about 1 cm below the carina.There were two locations to treat: one at 1'oclock in the field of view and one at 4 o'clock.The sites were right next to each other at the same level.The treating physician targeted the 1 o'clock site for the first spray.A pneumothorax was detected.Chest tubes were inserted and the patient recovered from the pneumothorax.Prior to the procedure the treating physician held a discussion about the potential for a pneumothorax (due the condition of the lungs from the stage 4 cancer) with the patient and the family.This report was originally sent to the test site on 21 dec 2018.

• Brand Name: TRUFREEZE CRYOSPRAY
• Common Device Name: UNIT CRYOSURGICAL ACCESSORIES
• Manufacturer (Section D): CSA MEDICAL, INC; 91 hartwell avenue; lexinton MA 02421
• MDR Report Key: 8889268
• Report Number: 3010140265-2019-00006
• Device Sequence Number: 13910553
• Product Code: GEH
• UDI-Device Identifier: 00857068006013
• UDI-Public: 00857068006013
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K172041
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/01/2020
• Device Model Number: CC3-01
• Device Catalogue Number: CC3-01
• Device Lot Number: 8506
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2018
• Initial Report FDA Received Date: 08/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR