| CPC A61B 5/01 (2013.01) [A61B 5/053 (2013.01); A61B 5/0536 (2013.01); A61B 5/0538 (2013.01); A61B 5/283 (2021.01); A61B 5/287 (2021.01); A61B 5/6853 (2013.01); A61B 18/02 (2013.01); A61B 2018/00351 (2013.01); A61B 2018/00357 (2013.01); A61B 2018/00375 (2013.01); A61B 2018/00642 (2013.01); A61B 2018/00791 (2013.01); A61B 2018/00797 (2013.01); A61B 2018/00839 (2013.01); A61B 2018/00863 (2013.01); A61B 2018/00875 (2013.01); A61B 2018/0212 (2013.01); A61B 2018/0262 (2013.01); A61B 2505/05 (2013.01); A61B 2562/046 (2013.01)] | 12 Claims |

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1. A method of determining lesion transmurality, the method comprising:
positioning a treatment element of a medical device in contact with an area of tissue, the treatment device being in fluid communication with a source of cryogenic fluid and including a cryoballoon, a plurality of mapping electrodes directly coupled to an outer surface of the cryoballoon and positioned to contact the area of tissue, a first plurality of electrodes, and a second plurality of electrodes different than the first plurality of electrodes;
recording, with each of the plurality of mapping electrodes, the first plurality of electrodes, and the second plurality of electrodes, from the area of tissue, at least one of a pre-treatment unipolar impedance measurement, a pre-treatment bipolar impedance measurement, a pre-treatment pace threshold measurement, and a pre-treatment electrogram amplitude;
transmitting, with each of the plurality of mapping electrodes, the first plurality of electrodes, and the second plurality of electrodes, at least one pre-treatment recording to a control unit having processing circuitry;
circulating the cryogenic fluid within the cryoballoon to lower the temperature of the cryoballoon to a temperature that is sufficient to ablate tissue;
ceasing the circulation of the cryogenic fluid within the cryoballoon;
recording, with each of the plurality of mapping electrodes, the first plurality of electrodes, and the second plurality of electrodes, from the area of tissue, at least one of a corresponding post-treatment unipolar impedance measurement, a post-treatment bipolar impedance measurement, a post-treatment pace threshold measurement, and a post-treatment electrogram amplitude;
transmitting, with each of the plurality of mapping electrodes, the first plurality of electrodes, and the second plurality of electrodes, the at least one post-treatment measurement to the control unit;
comparing, with the control unit, the at least one pre-treatment measurement to the at least one post-treatment measurement; and
determining, with the control unit, lesion transmurality in the area of tissue based on the comparison.
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